NDC 17312-016 Temporary Fibromyalgia Pain And Discomfort Relief

Atropa Belladonna - Bryonia Alba Root - Causticum - Phosphorus - Strychnos Nux-vomica Seed - Pulsatilla Vulgaris - Toxicodendron Pubescens Leaf -

NDC Product Code 17312-016

NDC CODE: 17312-016

Proprietary Name: Temporary Fibromyalgia Pain And Discomfort Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Atropa Belladonna - Bryonia Alba Root - Causticum - Phosphorus - Strychnos Nux-vomica Seed - Pulsatilla Vulgaris - Toxicodendron Pubescens Leaf - What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: DIAMOND (C48338)
Size(s):
13 MM
Imprint(s):
TRP
Score: 1

NDC Code Structure

  • 17312 - Trp Company
    • 17312-016 - Temporary Fibromyalgia Pain And Discomfort Relief

NDC 17312-016-14

Package Description: 1 BOTTLE in 1 PACKAGE > 70 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

NDC Product Information

Temporary Fibromyalgia Pain And Discomfort Relief with NDC 17312-016 is a a human over the counter drug product labeled by Trp Company. The generic name of Temporary Fibromyalgia Pain And Discomfort Relief is atropa belladonna - bryonia alba root - causticum - phosphorus - strychnos nux-vomica seed - pulsatilla vulgaris - toxicodendron pubescens leaf -. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

Labeler Name: Trp Company

Dosage Form: Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Temporary Fibromyalgia Pain And Discomfort Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ATROPA BELLADONNA 6 [hp_C]/1
  • BRYONIA ALBA ROOT 6 [hp_C]/1
  • CAUSTICUM 6 [hp_C]/1
  • PHOSPHORUS 6 [hp_C]/1
  • STRYCHNOS NUX-VOMICA SEED 6 [hp_C]/1
  • PULSATILLA VULGARIS 6 [hp_C]/1
  • TOXICODENDRON PUBESCENS LEAF 6 [hp_C]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MANNITOL (UNII: 3OWL53L36A)
  • SORBITOL (UNII: 506T60A25R)
  • CROSPOVIDONE (UNII: 68401960MK)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • COPOVIDONE (UNII: D9C330MD8B)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Trp Company
Labeler Code: 17312
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Temporary Fibromyalgia Pain And Discomfort Relief Product Label Images

Temporary Fibromyalgia Pain And Discomfort Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Belladonna HPUS 6c, 12c, 18c

Bryonia HPUS 6c, 12c, 18c

Causticum HPUS 6c, 12c, 18c

Magnesia Phosphorica HPUS 6c,12c,18c

Nux Vomica HPUS 6c,12c,18c

Pulsatilla HPUS 6c,12c,18c

Rhus Tox HPUS 6c,12c,18c
HPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

Belladonna HPUS - Chronic discomfort, Fatigue

Bryonia HPUS - Difficulty moving, Stiff joints, Acute soreness

Causticum HPUS - Muscle and nerve soreness

Magnesia Phosphorica HPUS - Cramping, Fatigue

Nux Vomica HPUS - Sleeplessness, Irritable bowels

Pulsatilla HPUS - Migrating soreness

Rhus Tox HPUS - Soft tissue discomfort

Uses

According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as: • Muscle soreness • Fatigue • Nerve / Soft tissue tenderness • Multiple tender points after diagnosis by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

  • USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN.This product is intended to complement, not replace, standard medical treatment.Initial worsening of symptoms may occur.A physician should always be consulted regarding Fibromyalgia to rule out serious causes.In case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

  • Stop use and ask a doctor if:Symptoms persist for more than 7 days or worsen, if new symptoms occur or if redness or swelling is present because these could be a sign of a serious illness.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • Suitable for adults and children 12 years and above.Dissolve entire tablet under tongue.Do not chew or swallow whole.Take 1 tablet 3 times a day or as directed by a physician.Use up to 6 times a day as needed.Take at least 10 minutes before or at least 10 minutes after eating or drinking.Children under the age of 12: consult a physician before use.

Other Information

  • There are no known contraindications.Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side cool dark location. Temporary Fibromyalgia Pain and Discomfort Relief® Fast Dissolving TabletsTM are homeopathic dilutions, for details see www.thereliefproducts.com.

Inactive Ingredients

Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

Otc - Questions

For more information and to order related products call toll free: 888-969-6855 or


trpcompany.com

* Please review the disclaimer below.